There exist various ways of administering drugs. They include oral tablets, orally disintegrating tablets, oral solution and injectables. However, aside from injectable form, which is invasive, the other administration routes may not be suitable for those patients who have difficulty swallowing, such as children and the elderly as well as people with buccal conditions. Instead, a more appropriate administration route for patients who have difficulty swallowing may be orally disintegrating film (ODF), which has recently been developed for the pharmaceutical industry and can be adapted for a plethora of popular drugs such as ondansetron. Due to its ease of handling and storage as well as the fact that it does not require swallowing solids such as tablets, administration of drugs via ODF is beneficial, especially for those who have difficulty swallowing.
An ODF typically has an established shelf-life of 2-3 years, depending on the active agent. However, it can be extremely sensitive to environmental moisture (Siddiqui et al., Advan. Biol. Res., 5(6): 291-303, 2011) as well as other environmental influences such as temperature and pH under various storage conditions. Therefore, functional excipients such as stabilizer (stabilizing agents), disintegrants, solubizer and filming-forming agents (in contrast to non-functional excipients such as sweetners, flavoring agents, etc. . . . ), have been described in other ODFs to enhance the ODF quality and performance properties.
As an illustration, there are various patents that describe application of ODF technology to ondansetron with functional excipients as additives. For example, U.S. Pat. No. 8,580,830, to Leichs et al., discloses adding pH adjusting agents to enhance ondansetron stability and to stimulate saliva for dissolving the film.
In addition, U.S. Pat. No. 8,663,687, to Myers et al. proposes preparing film compositions for delivery of drugs by including polyethylene oxide and saccharide-based polymer as a water soluble polymer composition in order to resolve any air trapping and void formation problems associated with conventional film forming process. The patent further claims incorporating active agents into nanoparticles or microparticles so as to ensure a non-self aggregating uniform heterogeneity.
Further, U.S. Pat. No. 8,658,201, to Singh et al., discloses a rapidly dissolving film having significant drug loading capability while providing sustained and controlled release of an active agent. This film is made up of high molecular weight hydrophilic polymers in combination with a rapidly dissolving polymeric material including water soluble sugars, semi-synthetic and synthetic polymers, and commercially available disintegrants.
Rather than using additives and complex formulations by the use of functional excipients as described in the patent listed above, there is a need for a fast acting ODF with a formulation that is easy to manufacture into a product and avoids a substantial number of additives that heretofore have been seen in many other ODF products while, at the same time, achieves desirable characteristics in an ODF product such as short buccal disintegration times, short dissolution times, strength for withstanding handling, minimum of gas bubbles, uniform distribution of API, smooth appearance appropriate for commercialization, etc. . . .